Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes (SALT)

Azienda Ospedaliero, Universitaria Pisana

Status: Enrolling

Conditions: Salt; Excess; Blood Pressure; Diabete Type 2

Treatments: Behavioral: Hypersodic/Hyposodic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06007157

SALT

Details and patient eligibility

About

The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.

Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:

• 24-h ambulatory blood pressure measurement;
• 24-h urine collection;
• bioimpedance analysis for body composition determination;
• blood and urine tests.

The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-65 years;
• both males and females;
• type 2 diabetes.

Exclusion criteria

• type 1 diabetes;
• insulin treatment;
• uncontrolled hypertension (SBP > 160 mmHg and/or DBP >95 mmHg);
• pregnancy;
• other acute or chronic conditions influencing blood pressure and glucose metabolism.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

SGLT2i-treated patients

Experimental group

Treatment:

Behavioral: Hypersodic/Hyposodic diet

Non SGLT2i-treated patients

Active Comparator group

Treatment:

Behavioral: Hypersodic/Hyposodic diet